Venitara launch, questions and answers

Companion to the launch news release.

What does Venitara do?

Venitara provides an AI regulatory platform and expert services for medical device, SaMD and in vitro diagnostic companies. It supports regulatory pathways, drawing up and reviewing technical documentation, evidence and gap review, and assessments of submission readiness.

What are the three ways to use Venitara?

Use the AI platform independently for working guidance and drafts; combine platform access with expert preparation or review; or buy expert services without using or subscribing to the platform. These choices describe how customers work with Venitara. Document and file assurance is described separately through Explore, Attest and Certify.

Can experts review documentation prepared elsewhere?

Yes. Customers can provide documents prepared by their own team or another supplier. The scope, document condition and outstanding work determine the engagement.

What are Explore, Attest and Certify?

Explore provides AI-generated working documents without expert review. Attest adds review by a named senior regulatory expert and a dated document-level attestation when readiness is established. Certify assesses the regulatory system and complete technical file through experts who did not author the documents, with a certificate recording submission readiness within the assessed scope.

What does an attestation cover?

It identifies the document version reviewed, the named expert, the criteria applied and the assessment date. It records readiness within that scope at that point in time. It does not cover documents outside the review. Documents that change may need further review.

Does Venitara Certification mean regulatory approval?

No. It records an independent assessment of submission readiness within a defined scope. Neither Venitara Attestation nor Venitara Certification is conformity assessment, regulatory approval, a Notified Body certificate or a guarantee of approval.

Who is responsible for the device and its file?

The manufacturer retains responsibility. Venitara records the work it performed and the scope it reviewed. AI guidance remains indicative until the relevant expert review has taken place.

Can assurance levels be mixed within one file?

Yes. Selected documents can be expert-reviewed while others remain working drafts. A complete file assessment covers the agreed system and documentation scope. Each document's status remains visible.

What does the service cover?

Agreed regulatory documentation work can cover intended purpose, classification rationale, quality systems, risk management, clinical and performance evidence, technical file preparation and post-market documentation. Data and AI governance support can be added to an engagement. Scope is confirmed before work begins.

What work must be sourced separately?

The supplied scope excludes design transfer, supplier controls, process validation and sterilisation validation. Venitara does not perform conformity assessment, guarantee approval or make submissions in its own name on behalf of a manufacturer.

Does the EU AI Act change what we need to file?

It adds a second regime on a separate clock. The AI Act's prohibitions and its AI literacy duty have applied since 2 February 2025, and its Article 50 transparency obligations have applied since 2 August 2026. A limited grace period to 2 December 2026 covers only the marking of AI-generated content under Article 50(2), and only for systems placed on the market before 2 August 2026. Regulation (EU) 2026/1744, the Digital Omnibus on AI, entered into force on 27 July 2026 and moved the high-risk obligations for AI embedded in regulated products, which is where an AI-enabled medical device sits, from 2 August 2027 to 2 August 2028. That date is now fixed rather than conditional, and the Omnibus left the Medical Device Regulation and the In Vitro Diagnostic Regulation unchanged. Data and AI governance support can be added to an engagement so both sets of obligations are addressed in one technical file rather than two.

How are the services priced?

The MedTech Compass is free. Paid platform access and expert services are priced separately. Expert review does not require a platform subscription. Published prices refer to stated scopes; work that varies is quoted before it begins. Notified Body and regulator fees are separate. See venitara.com/pricing.

What happens if a platform subscription ends?

Customers can export documents while their subscription is active and retain the downloaded files. Access to the workspace ends with the subscription.

Which markets are supported?

The launch covers the European Union, the United States and selected Middle East and North Africa markets. The requirements and delivery scope for each target market are agreed for the engagement. A connected record can support reuse of relevant information, while market-specific requirements still need to be addressed.

Who contracts with customers today?

Mangold Consultants contracts and invoices in its own name, using Venitara as a business designation. Incorporation of the joint venture company in Germany is in progress. HealthSeed AG and Mangold Consultants are its intended equal shareholders.

Where should a company start?

Use the free MedTech Compass for an indicative first view of the pathway and gaps, or contact Venitara directly to discuss expert services. venitara.com